NDA for First-of-Its-Kind Opioid Analgesic Submitted to FDA

A New Drug Application (NDA) has been submitted for NKTR-181 (Nektar Therapeutics), an opioid analgesic molecule designed to provide pain relief with fewer CNS-mediated side effects such as euphoria.

NKTR-181 is a long-acting selective full mu-opioid agonist; it is not a prodrug or a reformulation of an existing opioid. This investigational agent has low permeability across the blood-brain barrier, which slows its rate of entry into the brain and reduces dopamine release.

Given its 14-hour elimination half-life, the treatment is being evaluated as a twice-daily regimen for pain control.

Steve Doberstein, PhD, Chief Development Officer at Nektar Therapeutics said “This innovative investigational medicine separates analgesic efficacy from the high levels of euphoria that too often lead to the abuse and addiction of traditional opioids.”